Intraluminal retractor

ABSTRACT

An intraluminal retractor includes a shapeable element formed by a series of shaping segments. The shaping segments may be associated with one another in a relaxed configuration that imparts the shapeable element with a linear, substantially linear or curvilinear shape to enable its insertion into an interior space within a subject&#39;s body. When actuated, the shaping segments may assume a contracted configuration that imparts the shapeable element with a desired shape, which may move an organ within which or against which the shapeable element is positioned, change a path of the organ and/or alter a shape of the organ. Methods for altering the locations, paths and/or shapes of organs are also disclosed.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.15/143,459, filed on Apr. 29, 2016 and titled INTRALUMINAL RETRACTOR,now U.S. Pat. No. 10,307,149 (“the '459 Application”). A claim for thebenefit of priority to the Apr. 29, 2015, filing date of U.S.Provisional Patent Application No. 62/154,555, titled INTRALUMINALRETRACTOR AND METHOD FOR USING THE SAME (“the '555 ProvisionalApplication”), was made is pursuant to 35 U.S.C. § 119(e) in the '459Application. The entire disclosures of the '555 Provisional Applicationand the '459 Application are hereby incorporated herein.

TECHNICAL FIELD

This disclosure relates generally to devices for selectively positioningor otherwise manipulating organs (e.g., hollow organs, organs adjacentto internal body cavities, etc.) within the body of a subject. Apositioning device, or intraluminal retractor, according to thisdisclosure may include shapeable element with a shape that will positiona hollow organ, such as an esophagus, in a desired manner. Systems thatinclude intraluminal retractors are also disclosed, as are methods forpositioning organs.

RELATED ART

Catheter or electrophysiology ablation is an invasive cardiac procedurethat uses radio-frequency (RF) energy or cyroablation to remove faultyelectrical pathways from the heart of a person—a patient—that is proneto developing cardiac arrhythmias, such as atrial fibrillation. Theprocedure involves advancing several flexible catheters through thepatient's blood vessels, usually via the femoral vein, internal jugularvein, or subclavian vein. The catheters are advanced into the heart andan ablation technique, such as the use of radiofrequency electricalimpulses, is used to induce and/or study various arrhythmias, and toablate the abnormal tissue that is causing the arrhythmia, if deemednecessary.

Certain ablation procedures include extensive radiofrequency ablation ofthe left atrial posterior wall of the heart. Radiofrequency ablation inthis location carries the potential risk of collateral damage tostructures adjacent to the left atrial posterior wall, including theesophagus. Esophageal injury is associated with numerous co-morbiditiesand a high mortality rate. Studies have shown esophageal injury withmucosal changes, which are consistent with the thermal injuries that mayhappen during ablation procedures, occur at a rate as high as 50% afterablation procedures. Up to 26% of patients suffer from more seriousnecrosis and/or ulcers. The most worrisome collateral damage is anatrial esophageal fistula, estimated to occur at a rate of approximately0.5%; however, underreporting is likely, and the true incidence isunknown and could likely be higher. While the likelihood of anatrial-esophageal fistula is low, it is almost always a lethalcomplication. Fistula formation is thought to occur due to conductiveheat transfer to the esophagus that causes trans-mural tissue injuryleading to a fistulous connection between the esophageal lumen and theleft atrium, leading to sepsis, stroke and eventual death.

The point of biggest potential vulnerability for the esophagus tothermal injury from cardiac procedures is during ablation of theposterior left heart chambers, including the left atrium. This is due toits close anatomic position of the esophagus. The esophagus is oftencompressed between the left atrium and surrounding structures, causingthe esophagus to take a flattened and ovoid shape that may contact abroad area that could span the majority of the posterior left atrialwall. This relationship makes the esophagus particularly vulnerable tothermal injury during ablation of any part of the posterior left atrialendocardium.

Unfortunately, there is no clear technique for accurately determiningthe precise location(s) where the esophagus contacts or is in closeproximity to the left atrium or any other part of the heart and, thus,for accurately determining whether or not the esophagus will bevulnerable during an ablation procedure. This uncertainty is compoundedby the fact that peristalsis and/or deglutition of the esophagus willchange the anatomic relationship between an individual's left atrium andhis or her esophagus during an ablation procedure.

SUMMARY

In one aspect, an intraluminal retractor is disclosed. An intraluminalretractor according to this disclosure may include a shapeable elementthat is configured to be placed in an internal cavity within a subject'sbody, such as a lumen or chamber as a hollow organ, a location next toan exterior of an organ, or any other suitable location. With theshapeable element in place within an internal cavity, it may physicallyalter the shape and/or location of at least a portion of at least oneorgan within the subject's body. Without limitation, the shapeableelement may be capable of placement within a lumen within a hollow organ(e.g., an esophagus, a portion of an intestine, a vessel, a duct, atube, etc.) in the body of a subject, such as a patient undergoing amedical procedure (e.g., a left atrial ablation procedure, etc.), and ofmoving a portion of the hollow organ during the medical procedure.

An intraluminal retractor according to this disclosure includes ashapeable element and an actuator. The shapeable element may be anelongated solid element that comprises at least one series or sequenceof shaping segments. The shaping segments, which are solid, may beoriented in a manner that will ultimately impart the elongated elementwith a desired configuration, such as a bend and a divergent sectionthat can move the location of the hollow organ in a desired manner(e.g., move the esophagus a suitable distance away from the left atriumof the heart, maintain the diversion of the esophagus for a sufficientlength, etc.). Depending upon the specific configurations of the shapingsegments, the orientations of the shaping segments may impart theshapeable element with a desired two-dimensional configuration or with adesired three-dimensional configuration.

The shapeable element may have a relaxed configuration, in which it mayhave a shape (e.g., linear, substantially linear, curvilinear, etc.)that will facilitate its introduction into the lumen of a hollow organ.Once the shapeable element is at a desired location within the interiorof the hollow organ, the actuator may be used to force it into acompressed configuration, in which it assumes its desired shape toprovide a desired result, such as diverting a path of the hollow organ.

The actuator may include one or more flexible elongated elements, suchas wires, cables, cords, or the like, that enable an individual, such asa health care provider, to place the shapeable element in its relaxedconfiguration or in its contracted configuration. In such an embodiment,each of the shaping segments of the shapeable element of theintraluminal retractor may include at least one passage or channel forreceiving a portion of the elongated element. When the elongatedelement(s) is (are) actuated (e.g., pulled to increase tension therein,etc.), the shaping segments are forced together in an end-to-endrelation to place the shapeable element in its contracted configuration.Conversely, tension in the elongated element(s) may be reduced to enablethe shapeable element to return to its relaxed configuration. Of course,intermediate configurations are also possible.

In a specific embodiment the shaping segments may resemble beads. Atleast some of the shaping segments include at least one end with aconfiguration that, when that end abuts an end of an adjacent shapingsegment, enables the adjacent shaping segments to be oriented at anangle of less than 180° to one another. In some embodiments, theconfigurations of the opposed ends of adjacent shaping segments mayenable the adjacent shaping segments to be oriented at two or moredifferent angles (e.g., 180° and an angle of less than 180°, etc.) toone another, depending upon the relative orientations of the shapingsegments. The shapes that the shapeable element can assume depend on thevarious configurations of the ends of adjacent shaping segments. Forexample, a desired curvature may be achieved by having a relative anglebetween the opposed ends of two adjacent shaping segments. Any number ofdesired angles and, thus, curvatures can be achieved. In regions whereno curvature is desired, the opposed ends of adjacent shaping segmentsmay be oriented perpendicular to the lengths of the adjacent shapingsegments so the adjacent shaping segments form an angle of 180° underactuation.

In another specific embodiment, adjacent shaping segments may behingedly secured to one another, and variations in the tension in one ormore flexible elongated elements of an actuator may change the shape ofthe shapeable element.

According to another aspect, this disclosure relates to methods foraltering the position, orientation and/or shape of one or more organswithin the body of a subject. In use, a shapeable element of anintraluminal retractor, while in its relaxed configuration, may beintroduced into the body of a subject, and into an interior of a holloworgan or into an internal cavity of the body. In some embodiments, theshapeable element may be placed at a particular location and in aparticular orientation within the hollow organ or internal cavity. Oncethe shapeable element is in place within the hollow organ or internalcavity, it may be moved at least partially into its contractedconfiguration. Contraction of the shapeable element may at leastpartially place it in its desired shape, which may, in turn, move,stretch or otherwise manipulate some or all of the hollow organ orinternal cavity. With an organ moved or otherwise manipulated in adesired manner, other procedures may be performed. After thoseprocedures are complete, the shapeable element may be returned to itsrelaxed configuration, which may reverse movement other manipulation ofpart or all of the organ. The shapeable element may then be removed fromthe hollow organ or internal cavity, and the shapeable element and thepositioning device may be removed from the body of the subject.

Other aspects, as well as features and advantages of various aspects, ofthe disclosed subject matter will become apparent to those of ordinaryskill in the art through consideration of the ensuing description, theaccompanying drawings and the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings:

FIG. 1A schematically depicts an embodiment of an intraluminal retractorin a relaxed configuration, in which a shapeable element of theintraluminal retractor may be straight;

FIG. 1B schematically depicts the embodiment of intraluminal retractorshown in FIG. 1A in a contracted configuration, in which the shapeableelement may be bent or curved;

FIGS. 1C-1F illustrate various embodiments of shaping segments that maybe used to form the shapeable element of an intraluminal retractor;

FIGS. 2A-2C depict an embodiment of a shaping segment that may assembledaround an elongated element of an actuator of an intraluminal retractor;

FIG. 3A schematically depicts an embodiment of an intraluminal retractorwith a nominal configuration;

FIG. 3B schematically depicts an embodiment of the intraluminalretractor of FIG. 3A that has been customized by the addition of shapingsegments with non-nominal shapes to enable a shapeable element of theintraluminal retractor to be bent or curved in a desired manner;

FIG. 4A illustrates an embodiment of a shapeable element with itsshaping segments in a relaxed configuration;

FIG. 4B illustrates the embodiment of shapeable element shown in FIG. 4Awith its shaping segments in a contracted configuration;

FIG. 4C illustrates the embodiment of shapeable element shown in FIG. 4Awith the orientations of some of its shaping segments having beenrotated, and placed in a contracted configuration that imparts theshapeable element with a different shape than that illustrated by FIG.4B;

FIG. 5 depicts another embodiment of shapeable element, with its shapingsegments in a contracted configuration;

FIGS. 6 and 7 show branched embodiments of shapeable elements, withtheir shaping segments in different contracted configurations;

FIG. 8 illustrates an embodiment of an intraluminal retractor with itsshapeable element in a relaxed configuration;

FIG. 9 depicts an embodiment of shaping segments that may form theshapeable element shown in FIG. 8, as well as an embodiment of a hingedarrangement between adjacent shaping segments, with the shapeableelement and its shaping segments in a relaxed configuration;

FIG. 10 is an assembly view that schematically illustrates an embodimentof a relationship between the shaping segments of the embodiment ofshapeable element shown in FIG. 9 with elongated elements of an actuatorof the intraluminal retractor shown in FIG. 8 and a sleeve for theshapeable element;

FIG. 11 provides an end view of the embodiment of shaping segment shownin FIGS. 9 and 10;

FIG. 12 depicts the embodiments of shapeable element and shapingsegments shown in FIG. 9 in a contracted configuration; and

FIG. 13 illustrates the embodiment of intraluminal retractor shown inFIG. 8 with its shapeable element in a contracted configuration.

DETAILED DESCRIPTION

FIGS. 1A and 1B illustrate an embodiment of a portion of an intraluminalretractor 10 that includes an actuator 20 and an elongated shapeableelement 15 made up of a plurality of shaping segments 30 a, 30 b, 30 c,etc. The actuator 20 comprises a flexible, elongated element 22, such asa wire (e.g., a metallic wire, a polymeric wire, etc.), a cable or acord. Each shaping segment 30 a, 30 b, 30 c, etc., of the shapeableelement 15 resides on the elongated element 22 of the actuator 20 and ispositioned along a portion of a length of the elongated element 22.

Each shaping segment 30 a, 30 b, 30 c, etc., includes a body 32 with twoends 34 and 35 (shown as ends 34 b, 34 c and 35 a, 35 b). At least onechannel 36 extends through the body 32 of the shaping segment 30 a, 30b, 30 c, etc., from one end 34 a, 34 b, 34 c, etc., respectively, to theother end 35 a, 35 b, 35 c, etc., respectively.

In addition, one or more additional lumens 37 may extend through thebody 32 of each shaping segment 30 a, 30 b, 30 c, etc., to accommodatewires or other elongated medical instruments (e.g., catheters, tubes,etc.). Without limitation, an additional lumen 37 may receive a guidewire to enable insertion of the shapeable element 15 into a cavity whilethe shapeable element 15 is in a relaxed configuration and/or has alinear, substantially linear or curvilinear shape. An additional lumen37 may also receive a guide wire to enable rotation of the shapeableelement 15 once it is in place within the cavity within the subject'sbody, which may enable a user (e.g., a healthcare professional, etc.) toadjust an orientation of the shapeable element 15 while it is in itscontracted configuration.

The channel 36 of each shaping segment 30 a, 30 b, 30 c, etc., receivesa portion of the elongated element 22 of the actuator 20, enabling theshaping segment 30 a, 30 b, 30 c, etc., to reside on the elongatedelement 22. At least some of the shaping segments 30 a, 30 b, 30 c,etc., may be strung on the elongated element 22 by threading theelongated element 22 into and through the channels 36 of various shapingsegments 30 a, 30 b, 30 c, etc.

Optionally, as shown in FIGS. 2A-2C, a shaping segment 130 may have aso-called “clam shell” type configuration, in which two halves 132 a and132 b of the body 132 of the shaping segment 130 define correspondinghalves 136 a and 136 b of the channel 136 of the shaping segment 130.When the halves 132 a and 132 b of the body 132 of the shaping segment130 are at least partially separated from one another (they may, forexample, be connected along one edge by a hinge, such as a living hinge,etc.), a portion of an elongated element 22 (FIGS. 1A and 1B) may beinserted into a half 136 a, 136 b of the channel 136. As the halves 132a and 132 b are assembled with one another, the halves 136 a and 136 bof the channel 136 define a complete channel 136 and the portion of theelongated element 22 within half 136 a, 136 b of the channel 136 mayalso be received by and captured within the other half 136 b, 136 a ofthe channel 136. Optionally, when the halves 132 a and 132 b of theshaping segment 130 are assembled with one another, two halves 137 a and137 b of one or more lumens 137 may define a complete lumen 137.

The channel 36 may receive a portion of the elongated element 22 in amanner that enables rotation of the shaping segment 30 a, 30 b, 30 c,etc., about the portion of the elongated element 22. In someembodiments, the shaping segment 30 a, 30 b, 30 c, etc., may be rotatedabout the portion of the elongated element 22 to position it in aninfinite number of orientations relative to the elongated element 22 andrelative to one or more other shaping segments 30 a, 30 b, 30 c, etc.,that are carried by the elongated element 22. In other embodiments, theshaping segment 30 a, 30 b, 30 c, etc., may be positioned in a fixednumber of positions, or orientations, about the elongated element 22(e.g., incremental positions, etc., which may be defined by discretelongitudinal surfaces of the elongated element 22, longitudinal groovesat different locations around the circumference or perimeter of theelongated element, longitudinal protrusions at different locationsaround the circumference or perimeter of the elongated element, etc.).

FIG. 1A shows the shaping segments 30 a, 30 b, 30 c, etc., and theintraluminal retractor 10 in a relaxed configuration, in which adjacentshaping segments 30 a and 30 b, 30 b and 30 c, etc., are at leastpartially spaced apart from one another and in which the elongatedelement 22 of the actuator 20 may be linear or substantially linear. Inthe relaxed configuration, there may be little or no tension in theelongated element 22.

A distal end of the elongated element 22 may be secured in placerelative to the distal-most shaping segment 30 n of the shapeableelement 15. Tension may be introduced into the elongated element 22 bypulling the elongated element 22 proximally with an actuation feature(not shown in FIG. 1A or FIG. 1B) of the actuator 20, which may bemanually operated. The actuation feature may lock into place to maintaina desired amount of tension in the elongated element 22.

With tension in the elongated element 22 of the actuator 20, as shown inFIG. 1B, ends 35 a and 34 b, 35 b and 34 c, etc., of adjacent shapingsegments 30 a and 30 b, 30 b and 30 c, etc., respectively, have beenforced against each other, placing the shaping segments 30 a, 30 b, 30c, etc., and the intraluminal retractor 10 in a contractedconfiguration. With the intraluminal retractor 10 in the contractedconfiguration, the elongated element 22 assumes a shape defined by theconfigurations of the opposed, abutting ends 35 a and 34 b, 35 b and 34c, etc., of adjacent shaping segments 30 a and 30 b, 30 b and 30 c,etc., respectively, and the orientations of the adjacent shapingsegments 30 a and 30 b, 30 b and 30 c, etc. Depending upon the relativeorientations of the adjacent shaping segments 30 a and 30 b, 30 b and 30c, etc., and the opposed, abutting ends 35 a and 34 b, 35 b and 34 c,etc., of the adjacent shaping segments 30 a and 30 b, 30 b and 30 c,etc., the intraluminal retractor 10 may assume a linear configuration orany of a plurality of different non-linear configurations, such as thenon-linear configuration depicted by FIG. 1B.

Shaping segments 30 a and 30 c shown in FIGS. 1A and 1B include flatends 34 a, 35 a and 34 c, 35 c, respectively, that are oriented obliquerelative to the channels 36 of the shaping segments 30 a and 30 c andnon-parallel to one another. Shaping segment 30 b, which is also shownin FIGS. 1A and 1B, includes one flat end 34 b that is oriented obliquerelative to the channel 36 of that shaping segment 30 b and another flatend 35 b that is oriented perpendicular to the channel 36 of thatshaping segment 30 b. Other embodiments of shaping segments 30′, 30″,30′″ and 30″″ are shown in FIGS. 1C-1F, respectively. The embodiment ofshaping segment 30′ shown in FIG. 1C includes flat ends 34′ and 35′ thatare both oriented perpendicular to the channel 36′ of that shapingsegment 30′. FIG. 1D illustrates an embodiment of a shaping segment 30″with flat ends 34″ and 35″ that have oblique orientations relative tothe channel 36″ of that shaping segment 30″, with the flat ends 34″ and35″ being oriented parallel to each other. In FIG. 1E, an embodiment ofa shaping segment 30′″ that includes at least one convex end 34′″ and/orat least one concave end 35′″ (e.g., one convex end 34′″ and one concaveend 35′″, two convex ends, two concave ends, etc.). FIG. 1F showsanother embodiment of shaping segment 30′″, which may include at leastone end 34′″ with two flat surfaces that form a convex taper and/or atleast one end 35′″ with two flat surfaces that form a concave taper.

With returned reference to FIG. 1B, when the adjacent ends 35 a and 34b, 35 b and 34 c, etc., of adjacent shaping segments 30 a and 30 b, 30 band 30 c, etc., are forced together (e.g., increasing tension in theelongated element 22 of the actuator 20; see, e.g., FIGS. 8 and 13), therelative orientations of the shaping segments 30 a, 30 b, 30 c, etc.,and the adjacent ends 35 a and 34 b, 35 b and 34 c, etc., may impart theintraluminal retractor 10 with a desired shape. As illustrated by FIG.1B, the shaping segments 30 a, 30 b, 30 c, etc., may be oriented aboutthe elongated element 22 of the actuator 20 in a manner that imparts theintraluminal retractor 10 with a non-linear configuration or shape. Thatnon-linear configuration or shape may comprise a two-dimensionaldiversion or a three-dimensional diversion that may alter the path of anelongated hollow organ (e.g., the esophagus, a portion of an intestine,a vessel, a duct, a tube, etc.) when the intraluminal retractor 10 ispositioned within the elongated hollow organ and assumes a non-linearconfiguration or shape as it is placed in its contracted configurationwithin the elongated hollow organ.

As an alternative to an intraluminal retractor 10 that assumes a desiredshape when an actuator 20 increases tension within the elongated element22 to pull the shaping segments 30 a, 30 b, 30 c, etc., together (e.g.,by pulling the distal-most shaping segment proximally, etc.), adjacentshaping segments 30 a, 30 b, 30 c, etc., may impart the intraluminalretractor 10 with a desired configuration when they are orientedrelative to one another. For example, the opposed, or facing, ends 35 aand 34 b, 35 b and 34 c, etc., of adjacent shaping segments 30 a and 30b, 30 b and 30 c, etc., may be secured to one another as the adjacentshaping segments 30 a and 30 b, 30 b and 30 c, etc., are placed in theirdesired orientations. This may be accomplished in any of a variety ofways; for example, by use of tongue and groove connections (which wouldlimit each adjacent pair of adjacent shaping segments 30 a and 30 b, 30b and 30 c, etc., to two relative orientations and could be used torestrict the contracted configuration to a two-dimensionalconfiguration, or bend), by use of a snap fit (which could provide forthree or more discrete orientations between each pair of adjacentshaping segments 30 a and 30 b, 30 b and 30 c, etc., and provide forthree-dimensional arrangements, depending upon the shapes of thecooperating snap elements) or in any other suitable manner.

While FIG. 1B illustrates an intraluminal retractor 10 that assumes aparticular two-dimensional shape when its shaping segments 30 a, 30 b,30 c, etc., are placed in the depicted orientation and compressedtogether, it should be apparent that a variety of other shapes orconfigurations may be achieved by placing one or more of the shapingsegments 30 a, 30 b, 30 c, etc., in a different orientation, by using adifferent arrangements of shaping segments and/or by using shapingsegments 30′, 30″, 30′″ of different configurations. Customization ortailoring of the intraluminal retractor 10 may be achieved in part inthe order in which shaping segments 30 a, 30 b, 30 c, etc., as well asany shaping segments 30′, 30″, 30′″, are placed along the length of theelongated element 22 of the actuator 20.

Configurations of shaping segments 130 that may be placed on anelongated element 22 without requiring that the elongated element 22 bethreaded through their channels 136, such as the configuration ofshaping segments 130 shown in FIGS. 2A-2C, may facilitate suchcustomization and/or tailoring of an intraluminal retractor 110 (FIGS.3A and 3B). In addition, the use of shaping segments 130 with suchconfigurations may increase the speed with which (or decrease the timerequired to) customize or tailor an intraluminal retractor 10. Asillustrated by FIGS. 3A and 3B, an intraluminal retractor 110 with anominal configuration in which all of the shaping segments 30 a′, 30 b′,30 c′, etc., have the same shape (e.g., that of the shaping segment 30′depicted by FIG. 1C, etc.) may be tailored by introducing shapingsegments 130 (FIGS. 2A-2C) with one or more different shapes (e.g., thatof the shaping segment 30 a shown in FIGS. 1A and 1B) between adjacentshaping segments 30 a′ and 30 b′, 30 b′ and 30 c′, etc.

Various examples of possible configurations for an intraluminalretractor 10 according to this disclosure are depicted by FIGS. 4A-7.

FIG. 4A illustrates an embodiment of a shapeable element 215 for anintraluminal retractor. The shapeable element 215 includes a pluralityof shaping segments 230 a, 230 b, 230 c, etc., that have the sameconfigurations as shaping segments 30 a and 30 c of the intraluminalretractor 10 shown in FIGS. 1A and 1B. More specifically, each shapingsegment 230 a, 230 b, 230 c, etc., includes a body 232 with two ends 234and 235 that are oriented obliquely relative to a channel 236 extendingthrough the body 232. The ends 234 and 235 of the body 232 are alsooriented non-parallel to one another, imparting the body 232 and eachshaping segment 230 a, 230 b, 230 c, etc., with a trapezoidal shape.When the shaping segments 230 a, 230 b, 230 c, etc., of the shapeableelement 215 are oriented in the same direction, as shown in FIG. 4A, andthen forced against one another, or compressed, they assume thecontracted configuration shown in FIG. 4B. FIG. 4C shows an alternativecompressed configuration that may be used to enable the physicaldiversion of a portion of an elongated hollow organ.

In FIG. 5, an embodiment of a shapeable element 315 is shown withshaping segments 330 a, 330 b, 330 c, etc., that each have one end 334that is oriented perpendicular to the length of each shaping segment 330a, 330 b, 330 c, etc., and another opposite end 335 with an orientationthat is oblique to the length of the channel 336. When adjacent ends 335a and 334 b, 335 b and 334 c, etc., are arranged in the sameorientations about an elongated element 22 (FIGS. 1A and 1B) as oneanother and abut one another (e.g., are forced against each other, aresecured to each other, etc.), the intraluminal retractor 310 assumes thecontracted configuration shown in FIG. 5.

FIGS. 6 and 7 illustrate two configurations of a shapeable elements 415with a pair of divergent sections, which are referred to as branches415L and 415R. The shapeable element 415 includes a shaping segment 430a with an end 435 a that includes two surfaces 435 l and 435 r thattaper inwardly toward one another, or in a concave manner. Such aconfiguration enables the two branches 415L and 415R to diverge from theshaping segment 430, as would a shaping segment 30″″ with two flatsurfaces 435 a-l and 435 a-r that form a convex taper, such as thatshown in FIG. 1F. As illustrated, the end 435 a is configured to receivetwo shaping segments 430 b-l and 430 b-r with ends 434 b-l and 434 b-rthat are oriented obliquely to the lengths of the shaping segments 430b-l and 430 b-r. The subsequent shaping segments 430 c-l, 430 d-l, etc.,and 430 c-r, 430 d-r, etc., of each branch 415L and 415R may then bearranged to impart their respective branch 415L, 415R with a desiredshape, such as the curved loop shown in FIG. 6 or the parallel branches415L and 415R shown in FIG. 7.

In any of the foregoing embodiments, as well as other embodiments thatincorporate teachings of this disclosure, a sleeve may cover theshapeable element (see, e.g., FIGS. 8 and 13). A sleeve may prevent theshaping segments from binding tissues against which they are positioned,particularly as the shape of the elongated shapeable element is alteredwhile the elongated shapeable element contacts those tissues.

Turning now to FIGS. 8-13, another embodiment of intraluminal retractor510 is depicted. With specific reference to FIGS. 8 and 13, such anintraluminal retractor 510 includes an elongated shapeable element 515and an actuator 520. The elongated shapeable element 515 is configuredto be inserted into a lumen of an elongated hollow organ, such as anesophagus, a portion of an intestine, a vessel, a duct, a tube or thelike. In FIGS. 8 and 13, only a sleeve 540 of the elongated shapeableelement 515 is visible. The sleeve 540 covers a series of shapingsegments 530 that form the shapeable element 515, an embodiment of whichis depicted by FIG. 9.

In the illustrated embodiment, each shaping segment 530 includes a firstend 534 with a protruding hinge element 534 h and a second end 535 witha recessed hinge element 535 h. The recessed hinge element 535 h of eachshaping segment 530 is configured to receive a corresponding protrudinghinge element 534 h of an adjacent shaping segment 530, which couples apair of adjacent shaping segments 530 to one another. When a protrudinghinge element 534 h is properly assembled with a corresponding recessedhinge element 535 h, the adjacent shaping segments 530 that have beencoupled to each other may pivot relative to one another. In the depictedembodiment, each protruding hinge element 534 h is rounded, and has theappearance of a semi-circular disk. Each recessed hinge element 535 hcomprises a narrow rectangular slot extending into the second end 535 ofthe shaping segment 530, across a diameter of the shaping segment 530.These and similar configurations enable pivotal movement of theprotruding hinge element 534 h and the recessed hinge element 535 h in asingle plane, or two-dimensional movement of the adjacent shapingsegments 530 relative to one another; however, hinge elements thatprovide for a greater range of motion, or three-dimensional movement ofadjacent shaping segments relative to one another, are also within thescope of this disclosure.

As illustrated by the assembly view provided by FIG. 10, a series ofshaping segments 530 may reside within the lumen 542 of the sleeve 540.Such an arrangement may prevent the shaping segments 530 from bindingtissues against which the elongated shapeable element 515 (FIGS. 8, 9and 13) may be positioned (e.g., the tissues that form the inner wallsof a lumen of a hollow organ, the tissues that form an outer wall of anorgan within a body cavity within which the shapeable element 515 ispositioned, etc.), particularly as the shape of the elongated shapeableelement 515 is altered as the elongated shapeable element 515 residesagainst part of an organ.

FIG. 10 also shows that a pair of elongated elements 522 a and 522 b ofthe actuator 520 (FIGS. 8 and 13) may be assembled with each shapingsegment 530. More specifically, each elongated element 522 a, 522 b mayextend through a corresponding channel 536 a, 536 b that extends throughthe length of the shaping segment 530, with one end of each channel 536a, 536 b opening into the recessed hinge element 535 h at acorresponding end 535 of the shaping segment 530 and the other end ofeach channel 536 a, 536 b opening to an outer edge of the protrudinghinge element 534 h at the opposite end 534 of the shaping segment 530.More specifically, the channels 536 a and 536 b may be positioned closeto the ends of the protruding hinge element 534 h (see also FIG. 11) andof recessed hinge element 535 h (FIG. 9). Such positioning may enablethe elongated elements 522 a and 522 b to control pivotal movement ofadjacent shaping segments 530 as the tension in each elongated element522 a, 522 b is adjusted (e.g., increased in one elongated element 522a, 522 b, relaxed in the other elongated element 522 b, 522 a; etc.).

As illustrated by FIGS. 9 and 12, when the tension in an elongatedelement 522 a (FIG. 10) residing within the aligned channels 536 a of aseries of shaping segments 530 is increased (and, optionally, thetension in an elongated element 522 b (FIG. 10) residing within thealigned channels 536 b of the series of shaping segments 530 isdecreased, or relaxed), the shape of the elongated shapeable element 515may be altered. More specifically, the elongated shapeable element 515may move from the straight configuration shown in FIG. 9 to the bent orcurved configuration shown in FIG. 13.

In addition, with returned reference to FIGS. 9, 11 and 12, one or moreadditional lumens 537 may extend through the body of each shapingsegment 530 to accommodate wires (e.g., guide wires for enablinginsertion of the shapeable element 15 into a cavity within a subject'sbody, for enabling rotation of the shapeable element 15 once it is inplace within the cavity within the subject's body, etc.) or otherelongated medical instruments (e.g., catheters, tubes, etc.).

While the drawings illustrate shapeable elements with specific numbersof shaping segments, it should be understood that the drawings aremerely intended to provide an indication of the manner in which adjacentshaping segments may be associated with one another. A shapeable elementmay include any number of shaping segments that will impart theshapeable element with a desired shape. The dimensions of the shapingsegments and the shapeable element may also be tailored for a particularuse, or for use with a particular organ.

Although the foregoing disclosure provides many specifics, these shouldnot be construed as limiting the scope of any of the ensuing claims.Other embodiments may be devised which do not depart from the scopes ofthe claims. Features from different embodiments may be employed incombination. The scope of each claim is, therefore, indicated andlimited only by its plain language and the full scope of available legalequivalents to its elements.

What is claimed:
 1. An intraluminal retractor, comprising: an elongated element; a plurality of shaping segments on the elongated element, each shaping segment including: a body including a first half and a second half removably assemblable with each other over the elongated element to selectively define orientations of an adjacent pair of shaping segments of the plurality of shaping segments; a channel extending through a length of the body, the channel including a first half recessed in an abutting surface of the first half of the body and a second half recessed in an abutting surface of the second half of the body, the channel capable of receiving a portion of the elongated element and enabling each shaping segment to be oriented in a plurality of orientations about the portion of the elongated element; and ends, including a proximal end and a distal end opposite from one another; and an actuator that selectively enables: placement of adjacent shaping segments of the plurality of shaping segments in a relaxed state; or forcing the adjacent shaping segments against one another to place and/or hold the intraluminal retractor in a retracted state, orientations of adjacent shaping segments of the plurality of shaping segments about the actuator defining a shape of the intraluminal retractor while in the retracted state.
 2. The intraluminal retractor of claim 1, wherein at least one end of the ends of at least one shaping segment of the plurality of shaping segments comprises a flat surface oriented perpendicular to a length of the channel through the at least one shaping segment.
 3. The intraluminal retractor of claim 2, wherein the ends of the at least one shaping segment comprise flat surfaces oriented perpendicular to the length of the channel through the at least one shaping segment.
 4. The intraluminal retractor of claim 1, wherein at least one end of the ends of at least one shaping segment of the plurality of shaping segments comprises a flat surface oriented obliquely to a length of the channel through the at least one shaping segment.
 5. The intraluminal retractor of claim 4, wherein the ends of the at least one shaping segment comprise flat surfaces oriented obliquely to the length of the channel through the at least one shaping segment.
 6. The intraluminal retractor of claim 5, wherein the flat surfaces of the ends of the at least one shaping segment are oriented parallel to one another.
 7. The intraluminal retractor of claim 5, wherein the flat surfaces of the ends of the at least one shaping segment are oriented non-parallel to one another.
 8. The intraluminal retractor of claim 7, wherein the flat surfaces of the ends of every shaping segment of the plurality of shaping segments are oriented non-parallel to one another.
 9. The intraluminal retractor of claim 1, wherein a first end of the ends of at least one shaping segment of the plurality of shaping segments comprises a convex surface.
 10. The intraluminal retractor of claim 9, wherein a second end of the ends of another shaping segment of the plurality of shaping segments adjacent to the first end of the at least one shaping segment comprises a concave surface capable of mating in a plurality of orientations with the convex surface of the first end of the at least one shaping segment.
 11. An intraluminal retractor, comprising: an elongated element; a plurality of shaping segments positioned sequentially along a length of the elongated element, each shaping segment removable from and replaceable on the elongated element and including: a body including a first half and a second half capable of being assembled with each other over the elongated element to define an orientation of each shaping segment relative to an orientation of at least one adjacent shaping segment; a channel extending through a length of the body, the channel including a first half recessed in an abutting surface of the first half of the body and a second half recessed in an abutting surface of the second half of the body, the channel capable of receiving a portion of the elongated element and enabling each shaping segment to be oriented in a plurality of orientations about the portion of the elongated element; and ends, including a proximal end and a distal end opposite from one another, the intraluminal retractor having a relaxed state in which positions of adjacent shaping segments of the plurality of shaping segments are able to change relative to one another, the intraluminal retractor having a retracted state in which the plurality of shaping segments is rigid, positions of adjacent shaping segments of the plurality of shaping segments being substantially fixed relative to one another.
 12. The intraluminal retractor of claim 11, wherein at least one end of the ends of at least one shaping segment of the plurality of shaping segments comprises a flat surface oriented perpendicular to a length of the channel through the at least one shaping segment.
 13. The intraluminal retractor of claim 11, wherein the ends of at least one shaping segment of the plurality of shaping segments comprise flat surfaces oriented obliquely to a length of the channel through the at least one shaping segment.
 14. The intraluminal retractor of claim 13, wherein the flat surfaces of the ends of the at least one shaping segment are oriented non-parallel to one another.
 15. A method for moving a portion of an esophagus away from a left atrium of a heart, comprising: assembling a plurality of shaping segments with an elongated element in orientations to define a shapeable element that will deflect the esophagus in a desired manner, including: orienting a first member of each shaping segment in a desired position along the elongated element and relative to at least one adjacent shaping segment of the plurality of shaping segments; introducing a portion of the elongated element into a portion of a channel recessed within an abutting surface of the first member of each shaping segment; and securing a second member of each shaping segment over the abutting surface of the first member, with the portion of the elongated element within the channel recessed within the abutting surface of the first member; inserting the shapeable element into the esophagus while the shapeable element is in a relaxed state; and introducing tension into the shapeable element to bring the shapeable element into a retracted state to deflect the portion of the esophagus away from the left atrium of the heart without distending the esophagus.
 16. The method of claim 15, further comprising: conducting a procedure on the left atrium of the heart with the portion of the esophagus deflected away from the left atrium of the heart.
 17. The method of claim 16, wherein conducting the procedure comprises conducting an atrial ablation procedure.
 18. The method of claim 15, further comprising: changing at least one of a position, an orientation, and a configuration of the shapeable element within the portion of the esophagus.
 19. The method of claim 15, further comprising: placing the shapeable element back in the relaxed configuration; and with the shapeable element in the relaxed configuration, removing the shapeable element from the esophagus. 